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Pharmaceutical News and Articles

Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Feb. 23, 2018

Posted 2 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Chicken Salad Sold at Fareway Stores Linked to Salmonella Outbreak A salmonella outbreak that's sickened 65 people in five states is linked to chicken salad produced by Triple T Specialty Meats, Inc. and sold in delis at Fareway grocery stores in Illinois, Iowa, Minnesota, Nebraska, and South Dakota, the U.S.... Read more

How to Get That Perfect Shave

Posted today in Medical

SUNDAY, Feb. 25, 2018 -- Guys, a perfect shave may be more about preparation and technique than the actual razor. "The perfect shave is a combination of art and trial and error," said Dr. Robert Anolik, a clinical assistant professor of dermatology at the New York University School of Medicine. "That said, there are steps you can take to help ensure a clean and comfortable shave," he said in an American Academy of... Read more

Summer Camp Tips for Kids With Asthma, Allergies

Posted yesterday in Medical

SATURDAY, Feb. 24, 2018 -- Your children may already be looking forward to summer camp. But when it comes to kids with asthma or allergies, parents need to take extra steps in planning their outdoor experience. "Kids with allergies and asthma need an extra layer of preparation to ensure they stay healthy and enjoy their adventure," said Dr. Bradley Chipps, president of the American College of Allergy, Asthma and... Read more

Why Some Are Still Skeptical of Tanning Bed Risks

Posted 2 days ago in Medical

FRIDAY, Feb. 23, 2018 -- The health risks are high for young people who use tanning beds, but not all parents seem to see it that way. To figure out why that is, researchers polled more than 1,200 parents of U.S. kids aged 11 to 17 years. The investigators found that parents who are less likely to believe that indoor tanning is harmful for teens include: Fathers. Parents who'd used indoor tanning devices... Read more

As Stroke 'Liquefies' Brain Tissue, Lasting Harm May Spread

Posted 2 days ago in Medical

FRIDAY, Feb. 23, 2018 -- Brain tissue damaged by a stroke can liquefy, become toxic and then harm remaining healthy parts of the brain -- possibly causing dementia, new research in mice suggests. "Most people probably assume that the brain heals in the same way as other tissues, but it doesn't," researcher Kristian Doyle said in a news release from the University of Arizona College of Medicine in Tucson. "Dead... Read more

FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions

Posted 6 days ago in New Drug Approvals

BRIDGEWATER, N.J., Feb. 19, 2018 (GLOBE NEWSWIRE) -- Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a privately-held specialty pharmaceutical company developing novel central nervous system (CNS) treatments utilizing its proprietary osmotic drug delivery platform, announced today that the U.S. Food and Drug Administration (FDA) has approved Osmolex ER, an amantadine extended release tablet, for the tre... Read more

FDA Expands Approval of Imfinzi (durvalumab) to Reduce the Risk of Non-Small Cell Lung Cancer Progressing

Posted 10 days ago in New Drug Approvals

February 16, 2018 -- The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first treatment approved for stage III unresectable n... Read more

FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer

Posted 11 days ago in New Drug Approvals

February 14, 2018 -- The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. “The FDA evaluates a variety of methods t... Read more

Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain

Posted 12 days ago in New Drug Applications

AUSTIN, Texas, Feb. 13, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today the resubmission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for Remoxy ER, its lead drug candidate. The Company expects a six-month review cycle by FDA. “This NDA resubmission is a milestone that brings us closer to offering a new and different abuse-deterrent treatment o... Read more

FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene

Posted 13 days ago in New Drug Approvals

BOSTON--(BUSINESS WIRE) Feb 12, 2018 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Symdeko (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who... Read more

U.S., EU and Japan Health Authorities Accept Regulatory Submissions For Review Of Pfizer’s Third-generation ALK Inhibitor Lorlatinib

Posted 13 days ago in New Drug Applications

February 12, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), previously treated with o... Read more

Icon Bioscience Receives FDA Approval for Dexycu (dexamethasone intraocular suspension) for Treating Inflammation Associated With Cataract Surgery

Posted 13 days ago in New Drug Approvals

Newark, CA (February 12, 2018) – Icon Bioscience, Inc. (IBI), a specialty biopharmaceutical company focused on utilizing its Verisome® drug-delivery platform to develop unique intraocular eye-care therapeutics, today announced that the United States Food and Drug Administration (FDA) has approved IBI’s New Drug Application (NDA) for Dexycu (dexamethasone intraocular suspension), a dropless, long-acting therapeutic fo... Read more

Verastem Submits NDA to FDA for Duvelisib for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma

Posted 2 weeks ago in New Drug Applications

BOSTON--(BUSINESS WIRE)--Feb. 7, 2018-- Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking full approval for its lead product candidate duvelisib, a first-in-class oral dual inhibitor of phosphoinositide-3-kinase... Read more

Paratek Completes Submission of New Drug Applications to U.S. FDA for Oral and Intravenous Omadacycline for Pneumonia and Skin Infections

Posted 3 weeks ago in New Drug Applications

BOSTON, Feb. 05, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that on February 2, 2018, it completed the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the Company’s once-daily oral and IV formulations of its broad-spectrum investigational antibiotic, omadacycline. Omadacycline is the first in a new class of tetracycline a... Read more

Alnylam Announces FDA Acceptance of New Drug Application (NDA) and Priority Review Status for Patisiran, an Investigational RNAi Therapeutic for the Treatment of Hereditary ATTR (hATTR) Amyloidosis

Posted 3 weeks ago in New Drug Applications

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 1, 2018-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of hereditary ATTR (hATTR) amyloidosis. The FDA also granted the... Read more

Monthly News Roundup - January 2018

Posted 3 weeks ago in Pharma Industry News

Opdivo Gains New Adjuvant Use in Melanoma Adjuvant therapy can reduce the risk of cancer recurrence follow surgery that removes the tumor and lymph nodes. Bristol-Myers Squibb’s Opdivo (nivolumab) is now the first PD-1 inhibitor approved as adjuvant treatment for any type of cancer. Based on a head-to-head trial, Opdivo significantly improved recurrence-free survival (RFS) versus Yervoy (ipilimumab) in patients w... Read more

FDA, FTC Warn Companies for Selling Illegal, Unapproved Opioid Cessation Products Using Deceptive Claims

Posted 4 weeks ago in Pharma Industry News

January 24, 2018 -- The U.S. Food and Drug Administration and the Federal Trade Commission today posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal. “The FDA is increasingly concerned with the proliferation of products claiming to treat o... Read more

Monthly News Roundup - December 2017

Posted 8 weeks ago in Pharma Industry News

Luxturna Gene Therapy OK’d for Rare Form of Vision Loss A historic approval, Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics is the first directly administered gene therapy that targets a disease caused by specific gene mutations. In December the U.S. Food and Drug Administration (FDA) approved Luxturna, used in patients with biallelic RPE65-mediated inherited retinal disease (IRD), a form of v... Read more

FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers

Posted 8 weeks ago in Pharma Industry News

Today, the Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the... Read more

FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer

Posted 9 weeks ago in Pharma Industry News

December 22, 2017 -- Today, the U.S. Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With today’s clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue,” said Robert Ochs, Ph.D., acting deputy direc... Read more

Loxo Oncology Announces Publication of Larotrectinib Clinical Data in The New England Journal of Medicine

Posted 5 days ago in Clinical Trials

STAMFORD, Conn., Feb. 21, 2018 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, and Bayer AG, Germany, today announced a publication in the February 22nd issue of the New England Journal of Medicine (NEJM) for larotrectinib in the treatment of pediatric and adult patients whose... Read more

Aimmune Therapeutics’ Pivotal Phase 3 PALISADE Trial of AR101 Meets Primary Endpoint in Patients With Peanut Allergy

Posted 6 days ago in Clinical Trials

BRISBANE, Calif.--(BUSINESS WIRE)--Feb. 20, 2018-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that its pivotal Phase 3 PALISADE efficacy trial of AR101 met the primary endpoint. In the United States, AR101 has U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for peanut-allergic... Read more

Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis

Posted 11 days ago in Clinical Trials

February 14, 2018 - Pfizer Inc. (NYSE:PFE) today announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and... Read more

Neurocrine Biosciences Will File New Drug Application for Opicapone for Parkinson's Disease Based on Existing Pivotal Clinical Trial Data

Posted 11 days ago in Clinical Trials

SAN DIEGO, Feb. 14, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, today announced that the U.S. Food and Drug Administration (FDA) has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone, an investigational drug for Parkinson's disease, after receiving meeting... Read more

Daré Bioscience, Inc. Enters into License and Collaboration Agreement for a Product with the Potential to Receive the First FDA Approval for Female Sexual Arousal Disorder

Posted 13 days ago in Clinical Trials

SAN DIEGO, Feb. 12, 2018 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a clinical-stage, women's biopharmaceutical company, today announced it has entered into an agreement to license SST-6007 (5% Topical Sildenafil Citrate Cream), a potential treatment for Female Sexual Arousal Disorder ("FSAD"), from Strategic Science & Technologies, LLC ("SST"). FSAD is characterized primarily by an inability to ... Read more